The Early Detection Research Network (EDRN) of the NCI has directed the establishment of several Biomarker Reference Laboratories to move biomarkers developed within the EDRN into the clinic. The University of Maryland Biomarker Reference Laboratory (UMB-BRL) will fulfill this mission. The UMB-BRL will enable biomarker validation by providing a wide range of core facilities and shared services, specialized equipment, and quality control systems, including CLIA certification and full clinical laboratories as well as molecular genetic assays within its versatile armamentarium. Resources provided will include histopathology, immunohistochemistry, clinical and research chemistry, molecular diagnostics, genomics, proteomics, flow cytometry research, biostatistics, an industrial ultra sensitive multiphoton detection technology laboratory, a broad tissue bank, and other resources. An expert team of leaders at UMB and industrial sites has been assembled to provide access to these core facilities and shared services, led by the PI, Dr. Stephen Meltzer, who has five years of experience participating in the EDRN as the PI of a Biomarkers Development Laboratory (BDL). The UMB-BRL will leverage both the EDRN experience of the PI and the considerable expertise of the leadership team to provide standardized procedures, high-throughput robust assays, generalizability, and clinical translation into CLIA-certified laboratories, in which the Co-PI, Dr. Sanford Stass, has extensive experience and expertise. Numerous extant collaboration within and outside UMB will guarantee maximum responsiveness to the demands of the EDRN. Lines of authority and an organizational structure have been clearly established at the UMB-BRL to ensure timely performance, effective communication, and rapid translation of biomarkers from the discovery phase into the clinical arena.